SIENTRA INC
Manufacturer adverse-event records for SIENTRA INC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 2019–2025 · thin-book · quiet Death-code · injury-heavy
Volume signature
SIENTRA INC is a thinner MAUDE footprint
SIENTRA INC accounts for 3,582 FDA MAUDE reports (#438 of 443, thin-book tercile). Death-coded event_type share is 0.00% (quiet); Injury share 99.3% (injury-heavy).
What the volume reading shows for SIENTRA INC
The standout signal for SIENTRA INC is filing volume: 3,582 adverse-event reports in FDA MAUDE (#438 of 443, thin-book). Death-coded event_type share sits at 0.00% (quiet).
As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.
Reports span 3 device types, led in this extract by Injury at 3,557 (99.3% of event_type total). Peak single-year volume reaches 1,969 reports across 6 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (3)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.